[Measurement of patient safety: a systematic review of the reliability and validity of adverse event detection with record review]. / Dossieronderzoek geschikt voor opsporen zorgschade?

OBJECTIVES: Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review. DESIGN: A systematic review of the literature. METHODS: We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled κ values (κ) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events. RESULTS: In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-raterreliability of the GTT and HMPS showed a pooled κ of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS. CONCLUSIONS: The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are methods that can be used to test concurrent validity.

Impact of a multifaceted strategy to improve perioperative diabetes care.

AIMS: To assess the impact of a multifaceted strategy to improve perioperative diabetes care throughout the hospital care pathway. METHODS: We conducted a controlled before-and-after study in six hospitals. The purpose of the strategy was to target four predominant barriers that obstruct optimal care delivery. We provided feedback on baseline indicator performance, developed a multidisciplinary protocol and patient information, and provided professional education. After a 6-month intervention, we determined the performance changes against three outcome indicators and nine process indicators using data on 811 patients with diabetes who underwent major surgery. The progress of the interventions was monitored closely. RESULTS: Two process indicators improved significantly in the intervention hospitals: the proportion of patients for whom glycaemic control had been evaluated preoperatively increased by 9% (P < 0.002) and the proportion of patients with blood glucose measurements within 1 h after surgery increased by 29% (P < 0.0001). Four other process indicators and all three outcome indicators improved more in the intervention hospitals than in the control hospitals, but the differences were not statistically significant. These included the proportion of patients with all glucose values at 6-10 mmol/l (+3%) and the proportion of patients with hyperglycaemia (-8%). The implementation of the multidisciplinary protocol was still ongoing after the 6-month intervention period. CONCLUSIONS: The multifaceted improvement strategy had a limited impact on the quality of perioperative diabetes care. This study demonstrates the complexity of improving perioperative diabetes care throughout the multiprofessional hospital care pathway.

Development and measurement of perioperative patient safety indicators.

BACKGROUND: To improve perioperative patient safety, hospitals are implementing evidence-based perioperative safety guidelines. To facilitate this process, it is important to provide insight into current practice. For this purpose, we aimed to develop patient safety indicators. METHODS: The RAND-modified Delphi method was used to develop a set of patient safety indicators based on the perioperative guidelines. First, a core group of experts systematically selected recommendations from the guidelines. Then, an expert panel of representative professionals appraised the recommendations against safety criteria, prioritized them and reached consensus about 11 patient safety indicators. Measurability, applicability, improvement potential (based on current practice) and discriminatory capacity of each indicator were pilot tested in eight hospitals. RESULTS: Seven structure, two process and two outcome indicators were developed covering the entire perioperative care process. Most indicators showed good applicability (N=11), improvement potential (N=6) and discriminatory capacity (N=7). Four indicators were difficult to measure. Improvement opportunities concerned the use of perioperative stops, timely administration of antibiotics, availability of protocols on perioperative anticoagulants and on prospective risk analysis of medical equipment, presence of a surveillance system for postoperative wound infections, and a morbidity and mortality registration. CONCLUSIONS: Using a systematic, stepwise method 11 patient safety indicators were developed for internal assessment, monitoring and improvement of the perioperative care process. There was large variation in guideline adherence between and within hospitals, identifying opportunities for improvement in the quality of perioperative care.

Perioperative diabetes care: room for improving the person centredness.

AIMS: Person centredness is an important principle for delivering high-quality diabetes care. In this study, we assess the level of person centredness of current perioperative diabetes care. METHODS: We conducted a survey in six Dutch hospitals, among 690 participants with diabetes who underwent major abdominal, cardiac or large-joint orthopaedic surgery. The survey included questions regarding seven dimensions of person-centred perioperative diabetes care. RESULTS: Complete data were obtained from 298 participants. The survey scores were low for many of the dimensions of person centredness. The dimensions 'information', 'patient involvement' and 'coordination and integration of care' had the lowest scores. Only half the participants had received information about perioperative diabetes treatment, and approximately one-third had received information about the effect of surgery on blood glucose values, target glucose values and glucose measurement times. Similarly, half the participants had an opportunity to ask questions preoperatively, and only one-third of the participants felt involved in the decision-making regarding diabetes treatment. Most participants knew neither the caregiver in charge of perioperative diabetes treatment nor whom to contact in case of diabetes-related problems during their hospital stay. CONCLUSIONS: Current perioperative diabetes care is characterized by a lack of patient information and limited patient involvement. These results indicate that there is ample room for improving the person centredness of perioperative diabetes care.

Meta-analysis of operative mortality and complications in patients from minority ethnic groups.

BACKGROUND: Insight into the effects of ethnic disparities on patients' perioperative safety is necessary for the development of tailored improvement strategies. The aim of this study was to review the literature on safety differences between patients from minority ethnic groups and those from the ethnic majority undergoing surgery. METHODS: PubMed, CINAHL, the Cochrane Library and Embase were searched using predefined inclusion criteria for available studies from January 1990 to January 2013. After quality assessment, the study data were organized on the basis of outcome, statistical significance and the direction of the observed effects. Relative risks for mortality were calculated. RESULTS: After screening 3105 studies, 26 studies were identified. Nine of these 26 studies showed statistically significant higher mortality rates for patients from minority ethnic groups. Meta-analysis demonstrated a greater risk of mortality for these patients compared with patients from the Caucasian majority in studies performed both in North America (risk ratio 1·22, 95 per cent confidence interval 1·05 to 1·42) and outside (risk ratio 2·25, 1·40 to 3·62). For patients from minority groups, the length of hospital or intensive care unit stay was significantly longer in five studies, and complication rates were significantly higher in ten. Methods used to identify patient ethnicity were not described in 14 studies. CONCLUSION: Patients from minority ethnic groups, in North America and elsewhere, have an increased risk of perioperative death and complications. More insight is needed into the causes of ethnic disparities to pursue safer perioperative care for patients of minority ethnicity.

Half-life systematics across the N=126 shell closure: role of first-forbidden transitions in the ß decay of heavy neutron-rich nuclei.

This Letter reports on a systematic study of ß-decay half-lives of neutron-rich nuclei around doubly magic (208)Pb. The lifetimes of the 126-neutron shell isotone (204)Pt and the neighboring (200-202)Ir, (203)Pt, (204)Au are presented together with other 19 half-lives measured during the "stopped beam" campaign of the rare isotope investigations at GSI collaboration. The results constrain the main nuclear theories used in calculations of r-process nucleosynthesis. Predictions based on a statistical macroscopic description of the first-forbidden ß strength reveal significant deviations for most of the nuclei with N<126. In contrast, theories including a fully microscopic treatment of allowed and first-forbidden transitions reproduce more satisfactorily the trend in the measured half-lives for the nuclei in this region, where the r-process pathway passes through during ß decay back to stability.

Measuring a caring culture in hospitals: a systematic review of instruments.

OBJECTIVE: To identify instruments or components of instruments that aim to measure aspects of a caring culture-shared beliefs, norms and values that direct professionals and managers to act caring in hospitals, and to evaluate their psychometric properties. DESIGN: Systematic review. DATA SOURCES: PubMed, CINAHL, EMBASE, PsychInfo, Web of Science and the International bibliography of the Social Sciences. STUDY SELECTION: Peer-reviewed articles describing (components of) instruments measuring aspects of a caring culture in a hospital setting. Studies had to report psychometric data regarding the reliability or validity of the instrument. Potentially useful instruments that were identified after the title and abstract scan were assessed on relevance by an expert panel (n=12) using the RAND-modified Delphi procedure. RESULTS: Of the 6399 references identified, 75 were examined in detail. 7 studies each covering a unique instrument met our inclusion criteria. On average, 24% of the instrument's items were considered relevant for measuring aspects of the hospital's caring culture. Studies showed moderate-to-high validity and reliability scores. Validity was addressed for 6 of the 7 instruments. Face, content (90%) and construct (60%) validity were the most frequently reported psychometric properties described. One study (14%) reported discriminant validity of the instrument. Reliability data were available for all of the instruments. Internal consistency was the most frequently reported psychometric property for the instruments and demonstrated by: a Cronbach's α coefficient (80%), subscale intercorrelations (60%), and item-total correlations (40%). CONCLUSIONS: The ultimate standard for measuring a caring culture in hospitals does not exist. Existing instruments provide partial coverage and lack information on discriminant validity, responsiveness and feasibility. Characteristics of the instruments included in this review could provide useful input for the design of a reliable and valid instrument for measuring a caring culture in hospitals.

Direct observation of long-lived isomers in 212Bi.

Long-lived isomers in (212)Bi have been studied following (238)U projectile fragmentation at 670 MeV per nucleon. The fragmentation products were injected as highly charged ions into a storage ring, giving access to masses and half-lives. While the excitation energy of the first isomer of (212)Bi was confirmed, the second isomer was observed at 1478(30) keV, in contrast to the previously accepted value of >1910 keV. It was also found to have an extended Lorentz-corrected in-ring half-life >30 min, compared to 7.0(3) min for the neutral atom. Both the energy and half-life differences can be understood as being due a substantial, though previously unrecognized, internal decay branch for neutral atoms. Earlier shell-model calculations are now found to give good agreement with the isomer excitation energy. Furthermore, these and new calculations predict the existence of states at slightly higher energy that could facilitate isomer deexcitation studies.

Superallowed Gamow-Teller decay of the doubly magic nucleus 100Sn.

The shell structure of atomic nuclei is associated with 'magic numbers' and originates in the nearly independent motion of neutrons and protons in a mean potential generated by all nucleons. During ß(+)-decay, a proton transforms into a neutron in a previously not fully occupied orbital, emitting a positron-neutrino pair with either parallel or antiparallel spins, in a Gamow-Teller or Fermi transition, respectively. The transition probability, or strength, of a Gamow-Teller transition depends sensitively on the underlying shell structure and is usually distributed among many states in the neighbouring nucleus. Here we report measurements of the half-life and decay energy for the decay of (100)Sn, the heaviest doubly magic nucleus with equal numbers of protons and neutrons. In the ß-decay of (100)Sn, a large fraction of the strength is observable because of the large decay energy. We determine the largest Gamow-Teller strength so far measured in allowed nuclear ß-decay, establishing the 'superallowed' nature of this Gamow-Teller transition. The large strength and the low-energy states in the daughter nucleus, (100)In, are well reproduced by modern, large-scale shell model calculations.

Implementing strategic bundles for infection prevention and management.

Healthcare-associated infections (HAI) are considered to be the most frequent adverse event in healthcare delivery. Active efforts to curb HAI have increased across Europe thanks to the growing emphasis on patient safety and quality of care. Recently, there has been dramatic success in improving the quality of patient care by focusing on the implementation of a group or "bundle" of evidenced-based preventive practices to achieve a better outcome than when implemented individually. The project entitled IMPLEMENT is designed to spread and test knowledge on how to implement strategic bundles for infection prevention and management in a diverse sample of European hospitals. The general goal of this project is to provide evidence on how to decrease the incidence of HAI and to improve antibiotic use under routine conditions.

Three methods of multi-source feedback compared: a plea for narrative comments and coworkers' perspectives.

BACKGROUND: Doctor performance assessments based on multi-source feedback (MSF) are increasingly central in professional self-regulation. Research has shown that simple MSF is often unproductive. It has been suggested that MSF should be delivered by a facilitator and combined with a portfolio. AIMS: To compare three methods of MSF for consultants in the Netherlands and evaluate the feasibility, topics addressed and perceived impact upon clinical practice. METHOD: In 2007, 38 facilitators and 109 consultants participated in the study. The performance assessment system was composed of (i) one of the three MSF methods, namely, Violato's Physician Achievement Review (PAR), the method developed by Ramsey et al. for the American Board of Internal Medicine (ABIM), or the Dutch Appraisal and Assessment Instrument (AAI), (ii) portfolio, (iii) assessment interview with a facilitator and (iv) personal development plan. The evaluation consisted of a postal survey for facilitators and consultants. Generalized estimating equations were used to assess the association between MSF method used and perceived impact. RESULTS: It takes on average 8 hours to conduct one assessment. The CanMEDS roles 'collaborator', 'communicator' and 'manager' were discussed in, respectively, 79, 74 and 71% of the assessment interviews. The 'health advocate role' was the subject of conversation in 35% of the interviews. Consultants are more satisfied with feedback that contains narrative comments. The perceived impact of MSF that includes coworkers' perspectives significantly exceeds the perceived impact of methods not including this perspective. CONCLUSIONS: Performance assessments based on MSF combined with a portfolio and a facilitator-led interview seem to be feasible in hospital settings. The perceived impact of MSF increases when it contains coworkers' perspectives.

A systematic review on the influence of trial quality on the effect of garlic on blood pressure.

BACKGROUND: Garlic is a widely used herbal product for hypertension. Previous meta-analyses on the effect of garlic on blood pressure (BP) have been contradictory however. We hypothesised that methodological deficiencies may have contributed to this disagreement. We therefore evaluated whether trials reporting on the effect of garlic on BP had sufficient methodological qualities and a proper description of BP determination. METHODS: MEDLINE , EMBASE, AMED, the COCHRANE library, IBIDS and CINA HL were systematically searched for trials reporting on the effect of garlic on BP. Both the methodological quality and the quality of blood pressure measurement were appraised using predefined quality scores. RESULTS: 32 Studies were identified. Of these studies, 13 were included previously by other meta-analyses. The methodological quality of the studies was poor. Only four trials had adequate allocation concealment, no single trial reported an intention-to-treat analysis and blinding of the evaluators was done in three trials only. Moreover, half of the studies did not report any data on BP measurement. No trials reported on the arm level. Body position was described most often. All trials fulfilling a predefined cutoff point were conducted in normotensive subjects. CONCLUSION: The effect of garlic on blood pressure cannot be ascertained. Previous meta-analyses have been based on trials with inadequate study designs, methodological deficiencies and with too little information about blood pressure measurement. In our view, use of garlic cannot be recommended as antihypertensive advice for hypertensive patients in daily practice.

Schottky mass measurement of the 208Hg isotope: implication for the proton-neutron interaction strength around doubly magic 208Pb.

Time-resolved Schottky mass spectrometry has been applied to uranium projectile fragments which yielded the mass value for the 208Hg (Z=80, N=128) isotope. The mass excess value of ME=-13 265(31) keV has been obtained, which has been used to determine the proton-neutron interaction strength in 210Pb, as a double difference of atomic masses. The results show a dramatic variation of the strength for lead isotopes when crossing the N=126 neutron shell closure, thus confirming the empirical predictions that this interaction strength is sensitive to the overlap of the wave functions of the last valence neutrons and protons.

Search for the pygmy dipole resonance in 68Ni at 600 MeV/nucleon.

The gamma decay from Coulomb excitation of 68Ni at 600 MeV/nucleon on a Au target was measured using the RISING setup at the fragment separator of GSI. The 68Ni beam was produced by a fragmentation reaction of 86Kr at 900 MeV/nucleon on a 9Be target and selected by the fragment separator. The gamma rays produced at the Au target were measured with HPGe detectors at forward angles and with BaF2 scintillators at backward angles. The measured spectra show a peak centered at approximately 11 MeV, whose intensity can be explained in terms of an enhanced strength of the dipole response function (pygmy resonance). Such pygmy structure has been predicted in this unstable neutron-rich nucleus by theory.

Inflammation in deep vein thrombosis and the development of post-thrombotic syndrome: a prospective study.

BACKGROUND: The aim of this study was to investigate whether inflammatory markers (interleukin-6 [IL-6] and C-reactive protein [CRP]) in the acute phase of deep vein thrombosis (DVT) are associated with elevated venous outflow resistance (VOR), thrombosis score (TS), reflux and the development of clinical post-thrombotic syndrome (PTS). METHODS: In 110 patients with a first DVT, plasma concentrations of IL-6 and CRP were determined on the day of admission. VOR, TS and reflux were measured 7 days, 1 and 3 months after diagnosis. After 1 year patients were evaluated for PTS using the Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) classification and Villalta scale. RESULTS: Median levels of IL-6 and CRP were 7 pg mL(-1) and 21 mg L(-1), respectively. After 3 months, VOR was elevated in 33 patients (30%), TS in 33 (30%) and reflux in 57 (52%). Incidence of PTS was 36.7% using CEAP>or=3 and 35.4% using Villalta-scale>or=5. Elevated levels of IL-6 and CRP were related to higher outcomes of VOR after 3 months [relative risks (RR) 2.4 (95% CI 1.5-3.9) and 1.4 (1.1-3.3), respectively] and for IL-6 to TS [1.5 (1.1-2.1)]. For reflux no relation was found. After 90 days, elevated outcomes of VOR, TS and reflux were related to PTS after 1 year. The association of IL-6 and CRP with PTS was weak using the CEAP classification with a RR of 1.2 (0.7-2.2) and 1.8 (0.9-3.3) and absent according to the Villalta scale 0.6 (0.2-1.4) and 1.2 (0.6-2.5), respectively. CONCLUSION: The results of this study suggest that inflammation might play a role in incomplete thrombus clearance, venous outflow obstruction and the development of PTS after 1 year.

Multilayer compression bandaging in the acute phase of deep-vein thrombosis has no effect on the development of the post-thrombotic syndrome.

OBJECTIVE: The purpose of this randomized study was to evaluate the influence of immediate multilayer compression bandages before application of elastic stockings in the acute phase of deep-vein thrombosis (DVT) on development of the post-thrombotic syndrome (PTS). METHODS: Sixty-nine patients with acute symptomatic DVT were randomized to immediate bandaging (n = 34) or no bandaging (n = 35). After reduction of edema sized-to-fit elastic stockings were applied in all patients after 7-14 days. Follow-up visits and non-invasive examinations were planned after 7, 30 and 90 days and 1 year. Venous outflow resistance (VOR) was measured by strain gauge plethysmography. Thrombosis score (TS) and reflux were measured by duplex scanning. After one year patients were evaluated for clinical PTS using both the clinical scale of the CEAP classification and the Villalta score. RESULTS: Improvement of clinical symptoms and decrease of leg circumference was better on day 7 in the bandaging group, but after 1 and 3 months clinical symptoms had improved equally in both groups. In 7 patients in the no-bandaging group a bandage was applied after all because of persistent edema after 10 days. There were no differences in VOR, TS and reflux. Using the CEAP classification the incidence of PTS was 39% in patients with bandages and 42% in patients without bandages (RR 0.91, 95% CI 0.50-1.66). Using the Villalta score the incidence of PTS was resp. 29 and 33% (RR 0.87, 95% CI 0.41-1.8). There was no difference in severity of PTS. CONCLUSION: Immediate multilayer compression bandaging in the acute phase of DVT is effective in reducing edema and complaints in the first week, but has no effect on thrombus regression, valve incompetence and the development of clinical PTS after 1 year.

The Team Climate Inventory: application in hospital teams and methodological considerations.

OBJECTIVE: To test the validity, reliability and discriminating capacity of an instrument to assess team climate, the Team Climate Inventory (TCI), in a sample of Dutch hospital teams. The TCI is based on a four-factor theory of team climate for innovation. DESIGN: Validation study. SETTING: Hospital teams in The Netherlands. PARTICIPANTS: 424 healthcare professionals; 355 nurses working in 22 nursing teams and 69 nurses and doctors working in 14 quality-improvement teams. MAIN OUTCOME MEASURES: Exploratory and confirmatory factor analyses, Pearson's product moment correlations, internal homogeneity of the TCI scales based on Cronbach alpha, and the TCI capability to discriminate between two types of healthcare teams, namely nursing teams and quality-improvement teams. RESULTS: The validity test revealed the TCI's five-factor structure and moderate data fit. The Cronbach alphas of the five scales showed acceptable reliabilities. The TCI discriminated between nursing teams and quality-improvement teams. The mean scores of quality-improvement teams were all significantly higher than those of the nursing teams. CONCLUSION: Patient care teams are essential for high-quality patient care, and team climate is an important characteristic of successful teams. This study shows that the TCI is a valid, reliable and discriminating self-report measure of team climate in hospital teams. The TCI can be used as a quality-improvement tool or in quality-of-care research.

Possibilities for transborder cooperation in breast cancer care in Europe: a comparative analysis regarding the content, quality and evidence use of breast cancer guidelines.

To encourage transborder cooperation in breast cancer care in Europe, we explored possibilities with the German-Dutch border area as an example. Evidence-based breast cancer guidelines were searched and compared on the: (1) methodological quality (with AGREE (Appraisal of Guidelines for Research and Evaluation)), (2) content of recommendations and (3) evidence use. The methodological quality of the German (n=2) and Dutch guidelines (n=2) was generally sufficient and comparable, although the applicability and the editorial independence were not clearly documented in the Dutch guidelines. Regarding the content analysis, German recommendations were taken as a reference point, because of the highest AGREE scores. Twenty-one of 25 recommendations discussed in both guidelines were corresponding and 4 were different, 32 were not mentioned in the Dutch guideline. The guidelines shared little evidence (< or =11%). We conclude that there are possibilities to encourage transborder cooperation. The clinical context of our results should be examined by measuring the actual care in both countries preferably with quality indicators.